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Ophthalmology. 2014 Jul;121(7):1414-1420.e1. doi: 10.1016/j.ophtha.2014.01.027. Epub 2014 Mar 27.

Intravitreal aflibercept injection for macular edema due to central retinal vein occlusion: two-year results from the COPERNICUS study.

Author information

1
Ophthalmic Consultants of Boston, Boston, Massachusetts.
2
Palmetto Retina Center, West Columbia, South Carolina.
3
Retina-Vitreous Associates Medical Group, Beverly Hills, California.
4
Retina Consultants of Houston, The Methodist Hospital, Houston, Texas.
5
Regeneron Pharmaceuticals, Inc., Tarrytown, New York.
6
Bayer HealthCare, Berlin, Germany; Department of Neurology, University of Erlangen-Nürnberg, Erlangen, Germany.
7
Bayer HealthCare, Berlin, Germany; Klinik und Poliklinik fur Augenheilkunde, Universitatsklinikum Hamburg-Eppendorf, Hamburg, Germany.
8
Bayer HealthCare, Berlin, Germany; Department of Neurology, Heinrich-Heine-Universitat, Dusseldorf, Germany.
9
Wills Eye Hospital, Philadelphia, Pennsylvania. Electronic address: jhaller@willseye.org.

Erratum in

  • Ophthalmology. 2014 Nov;121(11):2293.

Abstract

PURPOSE:

To evaluate the efficacy and safety of intravitreal aflibercept injection (IAI) for the treatment of macular edema secondary to central retinal vein occlusion (CRVO).

DESIGN:

Randomized, double-masked, phase 3 trial.

PARTICIPANTS:

A total of 188 patients with macular edema secondary to CRVO.

METHODS:

Patients received IAI 2 mg (IAI 2Q4) (n = 114) or sham injections (n = 74) every 4 weeks up to week 24. During weeks 24 to 52, patients from both arms were evaluated monthly and received IAI as needed, or pro re nata (PRN) (IAI 2Q4 + PRN and sham + IAI PRN). During weeks 52 to 100, patients were evaluated at least quarterly and received IAI PRN.

MAIN OUTCOME MEASURES:

The primary efficacy end point was the proportion of patients who gained ≥ 15 letters in best-corrected visual acuity (BCVA) from baseline to week 24. This study reports week 100 results.

RESULTS:

The proportion of patients gaining ≥ 15 letters was 56.1% versus 12.3% (P<0.001) at week 24, 55.3% versus 30.1% (P<0.001) at week 52, and 49.1% versus 23.3% (P<0.001) at week 100 in the IAI 2Q4 + PRN and sham + IAI PRN groups, respectively. The mean change from baseline BCVA was also significantly higher in the IAI 2Q4 + PRN group compared with the sham + IAI PRN group at week 24 (+17.3 vs. -4.0 letters; P<0.001), week 52 (+16.2 vs. +3.8 letters; P<0.001), and week 100 (+13.0 vs. +1.5 letters; P<0.0001). The mean reduction from baseline in central retinal thickness was 457.2 versus 144.8 μm (P<0.001) at week 24, 413.0 versus 381.8 μm at week 52 (P = 0.546), and 390.0 versus 343.3 μm at week 100 (P = 0.366) in the IAI 2Q4 + PRN and sham + IAI PRN groups, respectively. The mean number (standard deviation) of PRN injections in the IAI 2Q4 + PRN and sham + IAI PRN groups was 2.7 ± 1.7 versus 3.9 ± 2.0 during weeks 24 to 52 and 3.3 ± 2.1 versus 2.9 ± 2.0 during weeks 52 to 100, respectively. The most frequent ocular serious adverse event from baseline to week 100 was vitreous hemorrhage (0.9% vs. 6.8% in the IAI 2Q4 + PRN and sham + IAI PRN groups, respectively).

CONCLUSIONS:

The visual and anatomic improvements after fixed dosing through week 24 and PRN dosing with monthly monitoring from weeks 24 to 52 were diminished after continued PRN dosing, with a reduced monitoring frequency from weeks 52 to 100.

PMID:
24679444
DOI:
10.1016/j.ophtha.2014.01.027
[Indexed for MEDLINE]
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